To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19 (MAOP3)

An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; SARS-CoV-2
• Intervention / Treatment: Drug: SCTA01; Other: Placebo

Detailed Description

The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group [SCTA01+ standard of care (SOC)] and control group (placebo + SOC) up to Day 29.

• Study Type: Interventional
• Enrollment (Anticipated): 690
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qiang Guo, PhD; Phone Number: 86-10-5862 8288; Email: qiang_guo@sinocelltech.com
• Study Contact Backup: Name: Zhanghua Lan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or non-pregnant female adults, ≥18 years old of age at the time of randomization;
• Participants should have at least one of COVID-19 risk factor;
• Participants should have at least 2 COVID-19 related symptoms;
• Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤7 days before randomization;
• First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;
• Participants are currently not hospitalized;
• Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;
• Women with childbearing potential must agree to use effective contraceptive methods during the study period;
• Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.

Exclusion Criteria:

• Have known allergies to any of the components used in the formulation of the SCTA01/placebo;
• Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema;
• Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA);
• Require mechanical ventilation or anticipated impending need for mechanical ventilation;
• Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study;
• Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
• Have any co-morbidity requiring surgery within <29 days, or that is considered life threatening within 29 days;
• Have a history of previous SARS-CoV-2 infection;
• Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;
• Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;
• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;
• Pregnant or lactating women;
• Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;
• Participants unable to follow the protocol during the study;
• Participants deemed inappropriate for enrollment by the investigator due to other factors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTA01 low dose +SOC; SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody	Drug: SCTA01; Diluted by 0.9% normal saline，IV
Experimental: SCTA01 middle dose+SOC; SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody	Drug: SCTA01; Diluted by 0.9% normal saline，IV
Experimental: SCTA01 High dose +SOC; SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody	Drug: SCTA01; Diluted by 0.9% normal saline，IV
Placebo Comparator: Placebo+SOC; SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody	Other: Placebo; IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29.	Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to sustained resolution of all COVID-19-related symptoms	Day 29
- Change in symptom score (total of ratings)	Day 3, 5, 7, 11, 15, 22, and 29
Time to symptom improvement;	Day 29
Proportion of participants admitted to hospital due to COVID-19	Day 29
Proportion of participants with ≥1 COVID-19 related hospitalization	Day 29
Proportion of participants with ≥2 COVID-19 related hospitalizations	Day 29
Total number of COVID-19 related hospitalization	Day 29
Proportion of participants who experience COVID-19 related emergency room (ER) visit	Day 29
Proportion of participants with ≥1 ER visit due to COVID-19	Day 29
Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29	Day 29
Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19	Day 29
Proportion of patients with all-cause mortality	Day 29
Proportion of participants with O2 requirement	Day 29
Proportion of participants with ventilation requirements	Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples	Day 8, Day 15
Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test.	Day 8, Day 15
Cumulative incidence of serious adverse events (SAEs)	Day 120
Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)	Day 120
Discontinuation or temporary suspension of infusions (for any reason)	Day 120
Number and proportion of patients with ADE	Day 120
Mean concentration-time profiles of SCTA01	Day 29
Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01	Day 1, Day 8, Day 29, and Day 120)

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Publications and helpful links

General Publications

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SCTA01-A301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No